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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K013921
Device Name PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
Applicant
Porges S.A.
Centre D'Affaires
La Boursidiere
Le Plessis Robinson Cedex,  FR 92357
Applicant Contact BERNARD ISMAEL
Correspondent
Porges S.A.
Centre D'Affaires
La Boursidiere
Le Plessis Robinson Cedex,  FR 92357
Correspondent Contact BERNARD ISMAEL
Regulation Number876.4620
Classification Product Code
FAD  
Date Received11/27/2001
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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